FDA.reportPublic FDA data

E.E.S

Product NDC
24338-136
11-digit product format
243380136
Labeler code
24338
Product ID
24338-136_0ca69356-c906-e9a9-e063-6394a90a9395
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin Ethylsuccinate
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
Application
NDA050207
Marketing category
NDA
Marketing start
2011-04-18
Substance
ERYTHROMYCIN ETHYLSUCCINATE
Active strength
200 mg/5mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
E.E.S
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERYTHROMYCIN ETHYLSUCCINATE200 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1014KSJ86F
Rxcui686400, 686405, 863603, 863606

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24338-136-10E.E.S200 mL in 1 BOTTLEGRANULE, FOR SUSPENSION20021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-136-10ML - Milliliter24338-136cd59097c-e167-4fef-aa1b-8cd769bfc7de12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Erythromycin EthylsuccinateACTIVE INGREDIENT1014KSJ86FE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
ErythromycinACTIVE MOIETY63937KV33DE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
D&C Red No. 30INACTIVE INGREDIENT2S42T2808BE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
magnesium stearateINACTIVE INGREDIENT70097M6I30E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
polacrilin potassiumINACTIVE INGREDIENT0BZ5A00FQUE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
powdered celluloseINACTIVE INGREDIENTSMD1X3XO9ME.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
propylene glycolINACTIVE INGREDIENT6DC9Q167V3E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
sorbic acidINACTIVE INGREDIENTX045WJ989BE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
starch, cornINACTIVE INGREDIENTO8232NY3SJE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
sucroseINACTIVE INGREDIENTC151H8M554E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPE.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [ARBOR PHARMACEUTICALS, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-136E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [AZURITY PHARMACEUTICALS, INC. (FORMERLY ARBOR PHARMACEUTICALS)]21Current NDC, Legacy NDC, 1 package rows20231217_b455bbdb-a3f1-470f-aa5f-ed83ac2e228d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863603E.E.S. 200 MG in 5 mL Oral SuspensionPSNb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863606E.E.S. 400 MG Oral TabletPSNb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686400erythromycin ethylsuccinate 200 MG in 5 mL Oral SuspensionPSNb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686405erythromycin ethylsuccinate 400 MG Oral TabletPSNb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863603erythromycin ethylsuccinate 40 MG/ML Oral Suspension [E.E.S.]SBDb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863606erythromycin ethylsuccinate 400 MG Oral Tablet [E.E.S.]SBDb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686400erythromycin ethylsuccinate 40 MG/ML Oral SuspensionSCDb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686405erythromycin ethylsuccinate 400 MG Oral TabletSCDb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863603E.E.S. 200 MG per 5 ML Oral SuspensionSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863603E.E.S. 200 Oral SuspensionSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863603E.E.S. 40 MG/ML Oral SuspensionSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863606E.E.S. 400 MG Oral TabletSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686400EES 40 MG/ML Oral SuspensionSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863603EES 40 MG/ML Oral Suspension [E.E.S.]SYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686405EES 400 MG Oral TabletSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
863606EES 400 MG Oral Tablet [E.E.S.]SYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21
686400erythromycin ethylsuccinate 200 MG per 5 ML Oral SuspensionSYb455bbdb-a3f1-470f-aa5f-ed83ac2e228d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24338-136-1024338013610200 mL in 1 BOTTLE (24338-136-10) 200 ml2011-04-180000-00-00NoNoCurrent